HHS OIG Proposed Rule on the Safe Harbor for Pharmaceutical Rebates: The Issues and Impact

Gain insights from an assay development expert as Dr. David Baker, of AstraZeneca, discusses how you can enable rapid measurement of cell proliferation, transfection efficiency, cell confluence and other cellular characteristics for assay optimization using live-cell imaging and high throughput flow cytometry. Establishing the characteristics of cell models is a key component of assay optimization processes performed at AstraZeneca. Learn how to use longitudinal live-cell imaging assays to characterize cells for assay development and assay endpoints. Examples will include how to measure cell confluence and assess the proliferation rate of different cell types to establish optimal assay conditions to screen for cytostatic or cytotoxic compounds in cancer cell lines.

The Pharmacovigilance & Drug Safety Webinar will be held on the 10th of March 2022 – Do not miss this one day conference full of interesting PV case studies, such as: Covid-19 Vaccines Safety and Effectiveness, Patient Support Programmes and Medical Information.

The classification of mosquito blood cells is controversial, complicated by the small size and number of cells one can obtain per mosquito, by the autofluorescent debris found in hemolymph, and the tendency of phagocytes to take up this autofluorescent debris. Much of the classification has been performed morphologically on cytospins of isolated cells. Imaging flow cytometry yields simultaneously acquired bright field, scatter, and fluorescent images of cells in suspension, enabling better resolution of rare cells from debris.

Manufacturing has been paid dividends for many years through the use of quality tools such as statistical process control, quality function deployment, vendor audit management, hazard analysis critical control points (HACCP), value stream analysis, and other valuation methods. In the highly regulated industries that manufacture pharmaceuticals, foods, and cosmetics, the quality control ‘scientists’ have been typically known to perform sampling and testing for determining the acceptability of finished products. During the past decade, the pharmaceutical industry has seen a significant regulator-industry aligned paradigm change and an important leap into the formality of quality improvement using quality tools. The paradigm of final product testing (and the myth of ‘testing quality into products’) has been challenged by both the industry and regulators. Recent industry and regulatory support of ‘risk-based’ concepts and principles are intended to produce a ‘desired state’ of industry development and production of pharmaceuticals that have a higher level of consistency in meeting purity, safety, and efficacy than in prior history.